(261 days)
The dynaMXTM Compression Plate is indicated for fixation of small fragments, osteolomics, atthrodeses, replantations, and reconstructions of small bones and small fragments.
The dynaMX™ Compression Plate provides a means of fixation for small bones and small fragments. The dynaMÄ™ Compression Plate is made of biocompatible Nitinol. The bridge of the implant is designed to exhibit superelastic properties at room temperature.
I apologize, but the provided text is a 510(k) summary for a medical device (dynaMX™ Compression Plate) and primarily focuses on establishing substantial equivalence to predicate devices through laboratory bench testing.
Therefore, the input document does not contain any information regarding clinical studies, acceptance criteria related to clinical performance, or the involvement of human readers or experts for ground truth establishment.
The document describes bench tests conducted to verify suitability and substantial equivalence, such as:
- Elastic Static Bending Testing
- Bending Fatigue Testing
- Cyclic Potentiodynamic Polarization Corrosion Testing
- Galvanic Corrosion Testing
- Compressive Force Performance
- Transformation Temperature Determination
- Package Seal Strength Verification
It also mentions testing for locking screws, including:
- Insertion and Removal Torque
- Torsional Strength
- Pullout Strength
Without information about clinical performance acceptance criteria and studies linked to human or algorithm performance, and ground truth establishment, I cannot fulfill your request for the specific details you've asked for.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.